Pure Global

Medtronic Advisaโ„ข DR A5DR01 Digital Dual Chamber Pacemaker - HSA Registration DE0506565

Access comprehensive regulatory information for Medtronic Advisaโ„ข DR A5DR01 Digital Dual Chamber Pacemaker in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0506565 and owned by Medtronic Inc.. The device was registered on January 07, 2022.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS D
DE0506565
Medtronic Advisaโ„ข DR A5DR01 Digital Dual Chamber Pacemaker
HSA Registration Number: DE0506565
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The Advisa DR system is indicated to restore physiologic heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The device is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity.

Device Classification
Device Class
CLASS D
Medical Speciality Area
Cardiovascular
Registration Information
Registration Number
DE0506565
Registration Date
January 07, 2022
Change Notification Approval Date
April 18, 2024
Retention Due Date
January 06, 2026
Product Owner
Short Name
Medtronic
Address
710 Medtronic Parkway, Minneapolis, MN 55432-5604, UNITED STATES
Registrant
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Importer
Address
50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384 50 PASIR PANJANG ROAD, MAPLETREE BUSINESS CITY, #04-51, SINGAPORE 117384
Model Information
Model Name(s)
Application Software Advisa DR
Model Identifier(s)
9995 A5DR01